Various medical procedures involve the introduction of a medical device into a body lumen. Some of these procedures may involve penetrating the wall of the body lumen, for example, to inject a therapeutic agent into the wall of the body lumen or the tissue surrounding the body lumen. Such a procedure may be used to treat stress urinary incontinence (SUI).
SUI is a urological disorder that exists in relatively large numbers of the human population and typically exists in older patients. Patients suffering from SUI often are unable to control and prevent the release of urine from the urethra, specifically in times of coughing, sneezing, laughing, or exercise. SUI may be caused by the weakening of muscle tissues, such as muscle tissues and fascia that coaxially surround the urethra. SUI also may be caused by weakening of bladder tissues, or a weakening or malfunction of the sphincter muscles at the bladder neck. Female patients have been known to suffer from SUI following pregnancy or a urological surgical procedure. Several treatments are known to eliminate or minimize the effects of SUI, such as installing a pessary into the female patient's vagina, installing a urethral sling into a patient, or injecting bulking agents into the patient's tissue surrounding the urethra.
In any procedure involving penetration of the wall of a body lumen, tenting or stretching of the luminal wall may occur during attempted penetration of the wall. Such tenting may increase the force that may be required to penetrate the wall with the cutting device, such as a needle. Such tenting also may reduce the accuracy with which the penetration may be performed.